FACT CHECK ABOUT HPV VACCINE AND CERVICAL CANCER

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Beatrix McDowell
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1 FACT CHECK ABOUT HPV VACCINE AND CERVICAL CANCER Dear Parents and Guardians, the HSE leaflet that accompanies the consent form for the HPV vaccine makes a number of statements designed to alleviate your concerns over the safety of the HPV vaccine. This document examines these statements for accuracy against available official and verifiable referenced data. WHO ARE WE? IFICA is the International Federation for Injured Children and Adults, a new international organisation based in Ireland. Our members include parents, doctors, scientists and patient organisations from all over the world. We represent those adversely affected by the HPV vaccine and wish to foster dialogue, compassion and understanding by all stakeholders, both public and private. Published by International Federation for Injured Children and Adults (IFICA) September 2018 PAGE 1

2 04039-HSEI-HPV-Leaflet-Proof#03-EN-FINAL.indd 1 02/07/ :50 FACT CHECK brochure, front The HPV vaccine protects against cervical cancer Information for parents and guardians vaccine Cancer leaflet, P2 The HPV vaccine protects against cervical cancer Ongoing analysis has shown that there is no scientific evidence linking HPV vaccines to any long-term medical condition This unqualified statement of efficacy is not true. The following information is taken directly from the Patient Information Leaflet (PIL) written by the vaccine manufacturer, Merck. 1. Vaccination with Gardasil is intended to protect against diseases caused by Human Papillomavirus (HPV) types 6, 11, 16, and 18. (Gardasil Package Leaflet) It does not protect against all cervical cancers 3. The length of time for which the vaccine is effective is not known at this time. According to the manufacturer Merck, 3.3% of trial participants have suffered systemic autoimmune disorders after Gardasil. These are long-term effects. 2 Independent studies into HPV vaccines have shown autoimmune issues and chronic illnesses have occurred after vaccination. 3 In court proceedings, the HPV vaccine has been identified as the cause of numerous deaths, including in the USA and Spain. 4 brochure, P3 Under Who should not receive HPV vaccine? It states that only girls who have had a very severe reaction to a previous HPV vaccine or are pregnant should be exempt. The adverse events monitoring agency, the Health Products Regulatory Authority (HPRA), advises that as yeast is used in its production process, those with yeast allergies should not have the vaccine. 5 This advice is not included in the leaflet. The HPRA whose function includes monitoring adverse reactions to medicines also stated on RTÉ that those with asthma are more likely to suffer a serious adverse reaction. The Merck PIL states that anyone with a systemic autoimmune disorder should seek medical advice before receiving the vaccine 6. The school pack does not disclose the Merck trial finding that pre-exposure to the HPV virus significantly increased the risk of cervical cancer for vaccine recipients 7 : injection of HPV vaccines into women who have concurrent [our emphasis] vaccine-relevant HPV type infections may increase the risk, by 44.6%, of developing high-grade precancerous lesions in the cervix. Therefore, it would be prudent to perform a sensitive HPV detection assay with accurate genotype determination on the patients to be vaccinated if prior HPV infection is suspected. Though tests exist for both yeast allergy and HPV pre-exposure, they are not currently available to parents. PAGE 2

P1 brochure, P2 Under HPV vaccine side effects, it is stated that severe allergic reactions with difficulty breathing are very rare (about 1 in 1 million).

The HPRA has already recorded 12 cases of anaphylaxis, a rate of 1 in 21,000. The serious side effects listed in the Merck PIL and in the Merck.

3 P1 brochure, P2 Under HPV vaccine side effects, it is stated that severe allergic reactions with difficulty breathing are very rare (about 1 in 1 million). It follows with a list of other mild, acute side effects. Under Does the vaccine work? it is stated Yes. In Australia, Sweden and Finland the vaccine has prevented up to 3 in every 4 pre-cancers. The HPRA has already recorded 12 cases of anaphylaxis, a rate of 1 in 21,000. The serious side effects listed in the Merck PIL and in the Merck.8, 9, 10 research data are not listed in the HSE information The adverse effects recorded on the HPRA database mirror the side effect listed in the manufacturer PIL. There are over 1,000 reports of side effects on the HPRA system, with over 300 unresolved. 60% of these reported adverse events have been classified as serious. 11 In Australia 12 and Sweden 13, there has been an increase in cervical cancer rates amongst the vaccinated population. Respective governmental statistics below show this. In 2007 (before the vaccine was introduced) the age 0-29 population had an incident rate of 3.7 per 100, in. In 2018, it is 9.9 per 100,000 in the age group This includes the vaccinated population and indicates that there is cervical cancer in a population where it did not exist before. Claims by the HSE that Finland have seen a reduction in cervical cancer due to the HPV vaccine are misleading. The Finnish Cancer Registry itself ascribes the decline to the introduction of cervical cancer screening in The HPV vaccine programme was not introduced until See below: The HSE figures are arrived at from an assessment of the HPV infection rates of the vaccinated strains, not on actual cervical cancer statistics from the respective cancer registries. The scientific evidence actually shows an increase in high-risk HPV strains other than those covered in the vaccine, amongst the vaccinated population. This phenomenon is called type replacement, where the reduction of one HPV strain leads to another strain becoming more virulent. PAGE 3

brochure, P2 P1 16-year-old girl is quoted: I m really glad my mam got me the vaccine a couple of years ago. As I get older I realise how important it is for me. HPV vaccine is recommended by.

4 brochure, P2 P1 16-year-old girl is quoted: I m really glad my mam got me the vaccine a couple of years ago. As I get older I realise how important it is for me. HPV vaccine is recommended by... This suggests that the advertising for the vaccine is aimed at underage girls. Such advertising is illegal under Irish law. Several organisations listed have been in receipt of significant funding from the manufacturers of HPV vaccines. One such organisation, The Irish Cancer Society, has received over 170,000 directly. We ask whether such an environment can lend itself to impartiality in advocacy. P1 Under HPV vaccine side effects it is stated: About 1 girl in 10 will get pain, swelling and redness at the injection site and/or headache. About 1 girl in 100 will get nausea, pain in the vaccinated arm and mild fever. About 1 girl in 1,000 to 1 girl in 10,000 will get an itchy rash or hives. Severe allergic reactions with difficulty breathing are very rare (about 1 in 1 million people). Occasionally girls faint after getting an injection. The girls are advised to sit down for 15 minutes after the vaccination. This helps prevent fainting. While WHO recommends the HPV vaccine, WHO Uppsala its drug monitoring agency recognises shortcomings in safety signal analysis (interpreting adverse events), advising that new approaches are needed to better identify what these signals mean. 16 These listed side effects are mild and transient. However, the Merck PIL side effects also include seizures, difficulty breathing, joint pain, muscle pain, Guillain-Barre Syndrome, vomiting, chills, confusion, unusual tiredness and weakness, skin infections, bleeding and bruising more easily, swollen glands (neck, armpit, or groin). Merck also recommends contacting your doctor or pharmacist if you suffer any of these side effects, even weeks or months after vaccination. 2.2% of Gardasil 9 recipients and 3.3% of Gardasil recipients reported a new medical condition potentially indicative of systemic autoimmune disorders. Merck also recognises long-term side effects on their safety statements about Gardasil within their Gardasil 9 documentation 17. It should be noted that in the USA the Cervical cancer rate is 8.1 cases per 100,000 women per year 18. Of each 100,000 vaccinated, 3,300 will report a new medical condition potentially indicative of systemic autoimmune disorders. In other words, the chance of acquiring a serious illness in the wake of receiving the HPV vaccine is 400 times greater than the likelihood of being diagnosed with cervical cancer later in life. PAGE 4

5 P2 Under Impacts of the HPV vaccine it is stated Precancerous growths of the cervix have been reduced by up to 75% in countries such as Australia, Sweden and Scotland. This is factually incorrect. To take the example of Australia: figures from the Australian health authorities clearly show the 75% reduction in cervical cancer rates occurred before the vaccine was introduced. This was the direct result of a smear testing programme introduced there in Since the vaccine was introduced, there has been a rise in cervical cancer rates 19. P2 This leaflet includes all the known scientifically proven side effects from HPV vaccine. The HSE leaflet does not contain the scientifically proven side effects as outlined by the manufacturer PIL, as outlined above (including seizures). It does not include the post-marketing reports that Merck declare in 20,21, 22. their safety data Gardasil 9 draws this comparison: As a comparison, of the 7,378 individuals who were administered GARDASIL and had safety follow-up, 185 reported a serious adverse event; representing 2.5% of the population. 23 PAGE 5

6 ttps://report.nih.gov/nihfactsheets/viewfactsheet.aspx?csid= Facebook.com/IFICAEurope/ PAGE 6

HPV WHAT YOU SHOULD KNOW ABOUT HPV, CERVICAL CANCER, AND GENITAL WARTS. CERVICAL CANCER IS CAUSED BY CERTAIN TYPES OF A VIRUS.

HPV WHAT YOU SHOULD KNOW ABOUT HPV, CERVICAL CANCER, AND GENITAL WARTS. CERVICAL CANCER IS CAUSED BY CERTAIN TYPES OF A VIRUS. WHAT YOU SHOULD KNOW ABOUT HPV, CERVICAL CANCER, AND GENITAL WARTS. CERVICAL CANCER IS CAUSED BY CERTAIN TYPES OF A VIRUS. Cervical cancer is cancer of the cervix (the lower part of the uterus that connects